JP2005043345A - Sensor format and constituting method of capillary filling diagnosing sensor - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an efficient manufacturing method and usage, in relation to a sensor for electrochemically analyzing a sample and manufacture of the sensor. <P>SOLUTION: In the electrochemical sensor, a flexible sheet, such as a polycarbonate sheet, is used, and a sensor component is easily manufactured as a sensor chemical is applied to the sensor component. The sensor can be manufactured by using a modular component, and production line and the electrochemical sensor can be constituted simply. Significant cost reduction and efficiency increase are achieved, in comparison with existing sensor style and sensor manufacturing technology. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates generally to electrochemical analysis, and more specifically to diagnostic sensors for fluid analysis.

  Electrochemical analysis is one technique that can be used to analyze both charged and neutral molecules. Such an analysis is very fast, requires only a small amount of sample and reagents, and is much cheaper than other analytical techniques. Electrochemical analysis can be used for a wide range of applications including testing of body fluids, such as glucose testing of blood samples. Electrochemical detectors do not require an optical carrier and as a result are much cheaper than absorption and fluorescence detectors. The electrochemical analysis system can test the sample collected in the sensor by capillary action.

  In general, most capillary fill sensors are manufactured by a method in which the active chemical area is captured within the shaped capture area. This assembly method requires precision molding and may require very precise printing of reagents and other drugs in very small areas. Furthermore, the use of a shaped or laminated structure formed to define and manufacture the capillary channel results in the sample being substantially surrounded by the walls formed. The unevenness of the wall may interfere with the flow of the sample due to friction, and variations in the wall between different sensors may cause variations in sample filling. The resulting sample filling variation affects the test results and reduces the overall accuracy of the analysis. Furthermore, existing sensors and sensor construction methods may increase the possibility of trapping bubbles. There is a need for an electrochemical sensor and sensor construction method that reduces or eliminates these problems to increase the efficiency and accuracy of electrochemical sample analysis.

  According to one embodiment of the invention, the electrochemical sensor consists of a flexible substrate with a chemical piece uniformly provided thereon.

  According to another embodiment of the invention, an electrochemical sensor is provided in which the size and shape of the electrode area is defined by precision stamping. The sample area of the electrochemical sensor consists of two sheets of similar shape forming a top and a bottom, leaving all sides of the sample area open, and a capillary channel for taking the sample. It is formed by forming.

  According to another embodiment of the present invention, an electrochemical sensor is provided in which the capillary passage is formed by folding the outer sheet over the end of the inner sheet.

  According to yet another embodiment of the invention, an electrochemical sensor is provided in which the working electrode and the reference electrode are manufactured by the same manufacturing operation.

  According to yet another embodiment of the present invention, linear ribbon processing is used to produce the electrodes and capillary regions.

  According to yet another embodiment of the invention, the electrochemical sensor is manufactured by stamping and lamination using relatively inexpensive high speed equipment.

  While the invention is susceptible to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and are described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. On the contrary, the invention includes all modifications, equivalents, and alternatives falling within the essence and scope of the invention as defined by the claims.

  The present invention generally relates to electrochemical sensors and methods for manufacturing electrochemical sensors. The sensor of the present invention can be used in various settings. One example is the use as a glucose test sensor.

  FIG. 1 shows an electrochemical sensor 10 of one embodiment of the present invention. The electrochemical sensor 10 includes a top sheet 12, a spacer sheet 14 and a bottom sheet 16. According to one embodiment of the present invention, the sheet used to construct the sensor 10 is a polycarbonate sheet, although other materials may be used in other specific embodiments. According to the embodiment shown in FIG. 1, the top sheet 12 and the bottom sheet 16 of the sensor 10 are sheets having the same shape, are inverted with respect to each other, and overlapped with the spacer sheet 14 disposed therebetween. Adhesives supplied to the top and bottom surfaces of the spacer sheet 14 may be used to secure the top sheet 12 and the bottom sheet 16 to the spacer sheet 14, or others as will be understood by those skilled in the art. The connecting means may be used.

  The top sheet 12 is provided with a top sheet notch 18 that aligns with the first spacer sheet notch 20 and exposes the bottom sheet electrode 22. Similarly, the bottom sheet 16 is provided with a bottom sheet notch portion 24 (shown in FIG. 4) that exposes the top sheet electrode 28 in alignment with the second spacer sheet notch portion 26 (shown in FIG. 4). ing. The electrode of the embodiment shown in FIG. 1 may be just an exposed portion of the structural material, or it may be a coating material on each of the topsheet 12 and bottomsheet 16, and the sensor 10 is connected or inserted into the reader. Can act as an electrical contact.

  The electrode interacts with the reader to allow analysis of the sample 30 collected in the sample filling area 32. The sample filling area 32 is between the top sample contact surface 34 and the bottom sample contact surface 36, as shown in FIG. In the embodiment shown in FIG. 1, the top sample contact surface 34 is formed integrally with the top sheet 12 and is connected to the main body of the top sheet 12 by a top neck 38. Similarly, the bottom sample contact surface 36 is formed integrally with the bottom sheet 16 and is connected to the main body of the bottom sheet 16 by the bottom neck 40. The overlap of the top sample contact surface 34 and the bottom sample contact surface 36 is combined with the gap provided by the spacer sheet 14 to draw the fluid sample 30 into the sample filling area 32 by capillary action and remain therein.

  Referring now to FIG. 2, the configuration of a sensor sheet according to one embodiment of the present invention is shown. A ribbon of structural material 42 is fed to a press 44. According to one embodiment of the present invention, a coating material 46 is provided on the ribbon 42 before the ribbon enters the press 44. The coating material 46 may be a surfactant to increase the spread of the sample as it enters the sample filling area 32, or may be a combination of reagents or chemicals with which the sample interacts, A combination of these may be used.

  The press 44 cuts the ribbon material 42 into a series of stock sheets 48. Each stock sheet 48 can be used as the top sheet 12 or the bottom sheet 16 in the configuration of the sensor 10 shown in FIG. Whether the stock sheet 48 is used as the top sheet or the bottom sheet of the sensor can be determined depending on the coating material 46. According to one embodiment of the present invention, the same coating material as the stock sheet 48 used as the bottom sheet is provided for the stock sheet 48 used as the top sheet. According to another embodiment, the coating material is provided only on the top sheet or only on the bottom sheet. Furthermore, different coating materials may be used for the two sheets.

  As shown in FIG. 2, a press 44 punches the ribbon material 42 in such a way that each stock sheet is provided with a stock sheet notch 50, a stock sheet neck 52 and a stock sheet sample contact surface 54. Therefore, in the embodiment shown in FIG. 1, the first stock sheet is provided in an inverted state on the second stock sheet, thereby forming the top sheet 12 and the bottom sheet 16.

  Referring now to FIG. 3, a side view of the electrochemical sensor 10 showing the structure of one embodiment of the sample fill area 32 is shown. The sample filling area 32 is located between a top sample contact surface 34 and a bottom sample contact surface 36, which may be coated with a coating material, either or both. According to one embodiment of the present invention, the space around the sample fill area 32 eliminates the need for ventilation and substantially eliminates air entrapment within the sample fill area 32. The volume of the sample filling area 32 is determined by the surface area of the top and bottom sample contact surfaces 34 and 36 and the distance w shown in FIG. According to one embodiment of the present invention, the distance w is about 0.005 inch, but in a particular embodiment, about 0.003 inch to about 0.0254 cm (0.005 inch). 010 inches) may be useful, and in some implementations wider or narrower distances may be useful. The distance w can be adjusted by changing the width of the spacer sheet 14.

  4 and 5, an electrochemical sensor 10 is shown in exploded view and rear view to more clearly illustrate the configuration of the sensor of one embodiment of the present invention. As shown in FIG. 4, the spacer sheet 14 is provided with first and second spacer sheet notches 20 and 26. In the embodiment shown in FIG. 4, the first spacer sheet notch 20 is aligned with the top sheet notch 18, and the second spacer sheet notch 26 is aligned with the bottom sheet notch 24. As a result, when the sensor 10 is formed, the alignment of the top sheet notch 18 and the first spacer sheet notch 20 exposes the bottom sheet electrode 22 as shown in FIG. Similarly, as shown in FIG. 1, the alignment of the bottom sheet notch 24 and the second spacer sheet notch 26 exposes the top sheet electrode 28.

  According to one embodiment of the present invention, the lower surface 56 of the top sheet 12 and the upper surface 58 of the bottom sheet 16 are coated with a conductor. Therefore, the electrochemical analysis of the sample 30 can be performed by connecting the exposed electrode to the analyzer. According to one embodiment of the present invention, a carbon coating is used to allow the top sheet bottom surface 56 and bottom sheet top surface 58 to conduct electricity, while certain embodiments of the present invention provide other A coating may be used. The alignment of the notches in the top sheet 12, spacer sheet 14 and bottom sheet 16 is further illustrated in FIG. 5, which shows a rear view of the sensor 10 of one embodiment of the present invention.

  Thus, some embodiments of the present invention take into account that the size and shape of the stock sheet 48 is determined by precision stamping or another precision manufacturing method, so that both the top sheet 12 and the bottom sheet 16 are the same or It can be formed by a method similar to Furthermore, the application of conductive components, reagents, surfactants or other chemicals is facilitated by the ability to apply the components uniformly to the entire ribbon of constituent material 42 or to a single strip of coating material 46; The requirement for precision printing or other precision placement of the coating material is relaxed or eliminated.

  Referring now to FIG. 6, an alternative embodiment sensor 60 of the present invention is shown. In the sensor 60 of the embodiment shown in FIG. 6, the outer sensor sheet 62 at least partially surrounds the inner sensor sheet 64. A spacer sheet 66 separates the outer sensor sheet 62 from the inner sensor sheet 64 and provides a sample filling area 68. According to one embodiment of sensor 60, outer sensor sheet 62, inner sensor sheet 64 and spacer sheet 66 are constructed of polycarbonate, although other materials such as polypropylene may be used in the construction of the sheet.

  The outer electrode area 70 is disposed on the inner surface of the outer sensor sheet 62, and the inner electrode area 72 is disposed on the surface of the inner sensor sheet 64. As shown in FIG. 7, the outer electrode area 70 is provided on the outer sensor sheet 62 as a substantially L-shaped layer. Similarly, the inner electrode area 72 is provided on the inner sensor sheet 64 as a generally L-shaped layer. According to the embodiment shown in FIGS. 6 and 7, the spacer sheet 66 is not provided with electrode areas.

  As shown in FIG. 6, the outer electrode area 70, which is a single electrode coating, is functionally divided into an outer electrode sample area 74 and an outer electrode contact area 76. Similarly, the inner electrode area 72 is functionally divided into an inner electrode sample area 78 and an inner electrode contact area 80. When the sample filling area 68 is filled with the sample, the electrode sample area contacts the sample and conducts electricity to the electrode contact area, which may be connected to the analyzer, and the electrochemical of the sample in the sample filling area 68 Enable analysis.

  According to one embodiment of the invention, the outer electrode area 70 is a reference electrode and the inner electrode area 72 is a working electrode. According to another embodiment of the present invention, the outer electrode area 70 may be a working electrode and the inner electrode area 72 may be a reference electrode. The reference electrode may be a printed carbon electrode or another type of electrode. The working electrode may be a printed carbon electrode with a reagent disposed thereon. According to one embodiment of the present invention, the entire working electrode is a printed carbon electrode, and the reagent is disposed only on the portion of the electrode that contacts the sample.

  Referring now to FIG. 8, the structure of the sensor 60 of one embodiment of the present invention is shown more clearly. A spacer sheet 66 is disposed over a portion of the inner sensor sheet 64, leaving the inner electrode sample area 78 exposed. According to one embodiment of the present invention, the spacer sheet 66 is coated with an adhesive on the sheet contact side so that the completed sensors 60 can be joined together. An outer sensor sheet 62 is disposed behind the inner sensor sheet 64. The outer sensor sheet 62 and the inner sensor sheet 64 can be bonded to each other by an adhesive disposed on the outer sensor sheet 62, the inner sensor sheet 64, or both. The front end portion 82 of the outer sensor sheet 62 is folded so as to surround a part of the inner sensor sheet 64 and the spacer sheet 66, and is adhered to the spacer sheet 66, thereby forming a sample filling area 68 as shown in FIG. ing. According to some embodiments of the present invention, the sensor 60 is joined by an adhesive method, such as a UV curable epoxy resin, instead of or in combination with an adhesive.

  Referring now to FIG. 9, there is shown a cross section of the sensor 60 as viewed from line 9-9 in FIG. The sample 84 is drawn into the sample filling area 68 by, for example, capillary action. Sample 84 is in contact with outer electrode sample area 74 and inner electrode sample area 78 to allow electrochemical analysis of the sample. In the embodiment shown in FIG. 9, the spacer sheet 66 forms one boundary of the sample filling area 68.

  Referring now to FIG. 10, the sensor 60 of one embodiment of the present invention is shown in use. Sample 84 is about to be drawn into sample fill area 68 by capillary action. Further, the sensor 60 is connected to an analytical instrument (not shown) by first and second instrument contacts 86 and 88. Although the sensor 60 is shown to be filled when connected to an analytical instrument, it will be appreciated that the sensor 60 may be initially filled and connected to the analytical instrument after filling. Instrument contacts 86 and 88 are connected to outer electrode contact area 76 and inner electrode contact area 80, respectively. As discussed above, the outer electrode contact area 76 is in conductive contact with the outer electrode sample area 74, and the inner electrode contact area 80 is in conductive contact with the inner electrode sample area 78, thereby causing the electrochemical properties of the sample 84. To enable dynamic analysis.

  Although the invention has been described with reference to one or more specific embodiments, those skilled in the art will recognize that many changes may be made to the invention without departing from the spirit and scope of the invention. For example, although the present invention has been generally described as relating to medical applications, it will be understood that any optical fluid testing application may utilize the principles of the present invention. Each of these embodiments and obvious variations thereof is considered to fall within the essence and scope of the claimed invention.

1 is a perspective view of an electrochemical sensor according to one embodiment of the present invention. FIG. 1 is a perspective view of sensor component manufacture according to one embodiment of the present invention. FIG. 1 is a side view of an electrochemical sensor of one embodiment of the present invention. FIG. It is a disassembled perspective view of the electrochemical sensor of one embodiment of this invention. 1 is an isometric rear view of an electrochemical sensor of one embodiment of the present invention. FIG. 1 is a perspective view of an electrochemical sensor according to one embodiment of the present invention. FIG. It is a disassembled perspective view of the electrochemical sensor of one embodiment of this invention. 1 is a perspective view of an electrochemical sensor assembly of one embodiment of the present invention. FIG. It is sectional drawing seen from the 9-9 line | wire of FIG. 1 is a perspective view of an electrochemical sensor of one embodiment of the present invention connected to an analytical instrument. FIG.

Claims (20)

A sensor for electrochemical analysis of a sample,
A top sheet having a top sample contact surface and a top sheet notch, and
A bottom sheet having a bottom sample contact surface and a bottom sheet notch, and
Between the top sheet and the bottom sheet, and having first and second spacer sheet notch portions, the first spacer sheet notch portion being aligned with the top sheet notch portion, A sensor including a spacer sheet in which a second spacer sheet notch is aligned with the bottom sheet notch.   The top sheet notch is aligned with the first spacer sheet notch to expose the bottom sheet electrode on the upper surface of the bottom sheet, and the bottom sheet notch is the second spacer sheet notch The sensor of claim 1, wherein the topsheet electrode is exposed on the lower surface of the topsheet in alignment.   The sensor according to claim 1, wherein the top sample contact surface is located above the bottom sample contact surface and is separated from the bottom sample contact surface by a distance substantially equal to the width of the spacer sheet.   The sensor of claim 3, wherein the separation is between about 0.0076 cm and about 0.0254 cm.   The top sample contact surface extends from the top sheet main body by the top neck, the bottom sample contact surface extends from the bottom sheet main body by the bottom neck, and further, the top sample contact surface and the bottom sample contact The sensor of claim 3, wherein a volume defined by a surface and having a height approximately equal to the width of the spacer sheet is adapted to receive a sample.   The sensor according to claim 1, wherein the top sample contact surface is coated with a mixture of a surfactant and a reagent.   The sensor according to claim 1, wherein the bottom sample contact surface is coated with a mixture of a surfactant and a reagent.   The sensor according to claim 1, wherein the top sample contact surface and the bottom sample contact surface are coated with a mixture of a sample and a reagent. A method of manufacturing a sensor for electrochemical analysis of a sample, comprising:
Preparing a ribbon of materials;
Coating a portion of the ribbon of material with a chemical mixture;
Inserting a ribbon of said material into a press;
Activating the press to punch a series of stock sheets from the ribbon and forming each stock sheet with a stock sheet sample contacting surface substantially uniformly coated with the chemical mixture by the press. .   The method of claim 9, wherein the chemical mixture is a reagent.   The method of claim 9, wherein the chemical mixture is a surfactant.   The method of claim 9, wherein the chemical mixture is a mixture of one or more reagents and a surfactant.   The method of claim 9, further comprising inserting a spacer sheet between a first stock sheet of the stock sheet and a second stock sheet of the stock sheet.   Activating the press to punch a series of stock sheets further comprises punching stock sheet notches in each of the stock sheets, and the method includes spacers having first and second spacer sheet notches Inserting a sheet between a first stock sheet of the stock sheet and a second stock sheet of the stock sheet, wherein the first spacer sheet notch is the first stock sheet of the stock sheet. 10. The method of claim 9, wherein the second spacer sheet notch is aligned with the stock sheet notch on the stock sheet, and the second spacer sheet notch is aligned with the stock sheet notch on the stock sheet. . A sensor for electrochemical analysis of a sample,
An inner sensor sheet having first and second sides, wherein an inner electrode area is provided on at least a portion of the first side;
A spacer sheet having first and second side faces, at least a part of the first side face being connected to a part of the first side face of the inner sensor sheet;
And an outer sensor sheet connected to at least a portion of the second side surface of the inner sensor sheet, wherein a tip portion of the outer sensor sheet has the inner sensor A portion of the sheet and the spacer sheet are folded so as to surround at least a portion, and are further connected to the second side surface of the spacer sheet, so that a part of the outer sensor sheet and a part of the inner sensor sheet And a sensor that forms a sample fill area delimited by a portion of the spacer sheet.   The sensor of claim 15, wherein the inner electrode area includes an inner electrode sample area and an inner electrode contact area, the inner electrode sample area being exposed to the sample filling area.   The sensor according to claim 16, wherein the spacer sheet is bonded to a tip portion of the outer sensor sheet, and further bonded to a part of the inner electrode sheet to expose the inner electrode sample area.   The sensor of claim 15, wherein the outer electrode area includes an outer electrode sample area and an outer electrode contact area, the outer electrode sample area being exposed to the sample filling area.   The sensor of claim 18, wherein the outer electrode sample area is an exposed portion of the outer electrode area that is bounded by the spacer sheet and the inner sensor sheet.   The sensor according to claim 15, wherein the inner sensor sheet, the spacer sheet, and the outer sensor sheet are made of polycarbonate.

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